CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)

Breast Cancer Clinical Trial

— CARIATIDE  

Official title:

An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681122
• Other study ID #: NIS-OEU-ARI-2007/1
• Status: Completed
• Phase: N/A
• First received: May 20, 2008
• Last updated: January 15, 2016
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Finland: Ethics CommitteeFinland: Ministry of Social Affairs and HealthFinland: Finnish Medicines AgencyGreece: Ethics CommitteeGreece: Ministry of Health and WelfareGreece: National Organization of MedicinesItaly: Ethics CommitteeRomania: National Medicines AgencySweden: Regional Ethical Review BoardSwitzerland: EthikkommissionTurkey: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal woman with hormone sensitive early breast cancer

• Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks

Exclusion Criteria:

• Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation

• Concomitant adjuvant treatment with tamoxifen or exemestane

• Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Canberra	Australian Capital Territory
Australia	Research Site	Coffs Harbour	New South Wales
Australia	Research Site	Hobart	Tasmania
Australia	Research Site	Nambour	Queensland
Australia	Research Site	Newcastle	New South Wales
Australia	Research Site	Port Macquarie	New South Wales
Australia	Research Site	Toowoomba	Queensland
Australia	Research Site	Tweed Heads	New South Wales
Austria	Research Site	Linz	Upper Austria
Austria	Research Site	Salzburg
Austria	Research Site	St. Veit	Carinthia
Austria	Research Site	Vienna
Austria	Research Site	Weiz	Styria
Austria	Research Site	Wolfsberg	Carinthia
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Arlon
Belgium	Research Site	Bonheiden
Belgium	Research Site	Bornem
Belgium	Research Site	Boussu
Belgium	Research Site	Brussels
Belgium	Research Site	Charleroi
Belgium	Research Site	Dendermonde
Belgium	Research Site	Edegem
Belgium	Research Site	Eupen
Belgium	Research Site	Geel
Belgium	Research Site	Gent
Belgium	Research Site	Geraardsbergen
Belgium	Research Site	Gilly
Belgium	Research Site	Haine St Paul
Belgium	Research Site	Leuven
Belgium	Research Site	Li?ge
Belgium	Research Site	Libramont
Belgium	Research Site	Namur
Belgium	Research Site	Oostende
Belgium	Research Site	Ottignies
Belgium	Research Site	Overpelt
Belgium	Research Site	Rocourt
Belgium	Research Site	Seraing
Belgium	Research Site	Tournai
Belgium	Research Site	Turnhout
Chile	Research Site	Santiago	Metropolitana
Chile	Research Site	Temuco	Novena Region
Colombia	Research Site	Barranquilla	Atlantico
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Cali	Valle
Colombia	Research Site	Medellin	Antioquia
Colombia	Research Site	Neiva	Huila
Colombia	Research Site	Pasto	Nari?o
Croatia	Research Site	Osijek
Croatia	Research Site	Rijeka
Croatia	Research Site	Zagreb
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Opava
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Praha
Finland	Research Site	Helsinki
Finland	Research Site	Tampere
France	Research Site	Aix En Provence
France	Research Site	Ales
France	Research Site	Annecy
France	Research Site	Arpajon
France	Research Site	Avignon
France	Research Site	Beauvais
France	Research Site	Bordeaux
France	Research Site	Brest
France	Research Site	Brive La Gaillarde
France	Research Site	Colmar
France	Research Site	Creteil
France	Research Site	Cucq
France	Research Site	Dechy
France	Research Site	Evreux
France	Research Site	GAP
France	Research Site	Grenoble
France	Research Site	Hyeres
France	Research Site	La Seyne Sur Mer
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Mareuil Les Meaux
France	Research Site	Marseille
France	Research Site	Mont de Marsan
France	Research Site	Mougins
France	Research Site	Nancy
France	Research Site	Nantes
France	Research Site	Narbonne
France	Research Site	Nice
France	Research Site	Nimes
France	Research Site	Perigueux
France	Research Site	Perpignan
France	Research Site	Quimper
France	Research Site	Reims
France	Research Site	Rennes
France	Research Site	Rouen
France	Research Site	Saint Brieux
France	Research Site	Saint Cyr Sur Loire
France	Research Site	Saint Gregoire
France	Research Site	Saint Jean
France	Research Site	Saint Mande
France	Research Site	Saint Nazaire
France	Research Site	Strasbourg
France	Research Site	Thonon Les Bains
France	Research Site	Toulon
France	Research Site	Toulouse
France	Research Site	Valence
France	Research Site	Vannes
France	Research Site	Villeneuve Sur Lot
Greece	Research Site	Athens
Greece	Research Site	Patras	Achaia
Greece	Research Site	Piraeous
Greece	Research Site	Thessaloniki
Greece	Research Site	Trikala
Italy	Research Site	Bologna
Italy	Research Site	Cosenza
Italy	Research Site	Lido di Camaiore	Lucca
Italy	Research Site	Pavia
Italy	Research Site	Roma
Italy	Research Site	Treviso
Peru	Research Site	Lima
Peru	Research Site	Piura
Romania	Research Site	Alba-Iulia
Romania	Research Site	Baia Mare
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Oradea
Romania	Research Site	Suceava
Sweden	Research Site	Karlskrona
Sweden	Research Site	Skellefte?
Sweden	Research Site	Stockholm
Switzerland	Research Site	Baden
Switzerland	Research Site	Bern
Switzerland	Research Site	Lugano
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zurich
Turkey	Research Site	Ankara
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Eskisehir
Turkey	Research Site	Gaziantep
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Kayseri
Turkey	Research Site	Konya
Turkey	Research Site	Malatya
Turkey	Research Site	Mersin
United Kingdom	Research Site	Brighton
United Kingdom	Research Site	Bristol
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Cheltenham
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	Macclesfield
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Scarborough
United Kingdom	Research Site	Shrewsbury
United Kingdom	Research Site	St Albans	Hertfordshire
United Kingdom	Research Site	York
Venezuela	Research Site	Caracas	Distrito Capital
Venezuela	Research Site	Valencia	Estado Carabobo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Chile,  Colombia,  Croatia,  Czech Republic,  Finland,  France,  Greece,  Italy,  Peru,  Romania,  Sweden,  Switzerland,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.		once after one year	No
Secondary	Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:		After one and two years.	No
Secondary	Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.		After one and two years	No
Secondary	Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.		After one and two years	No